MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLLECTOR; SHARPS COLLECTORS

Catalog Number	323487
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: level a investigation.Complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_1__; occurrence: unable to perform complaint lot history check due to unknown lot number.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Level a event no dhr or qn review is required.As no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.Investigation conclusion: as no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that bd¿ sharps collector had no lid.No serious injury or medical intervention was reported.Verbatim: "material no: 323487 batch no: unknown.It was reported: that the home sharps container just purchased has no lid verbatim: 323487 this home sharps container just purchased has no lid.Sending new container.".

• Brand Name: BD¿ SHARPS COLLECTOR
• Common Device Name: SHARPS COLLECTORS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8433254
• Report Number: 2243072-2019-00516
• Device Sequence Number: 2015454
• Product Code: FMI
• UDI-Device Identifier: 10885403960109
• UDI-Public: 10885403960109
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 323487
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other